Process Development Engineer

Process Development Engineer ROCGJP00039917

• Hourly pay: $48/hr
• Worksite: Leading biotechnology company (Tucson, AZ 85755 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 24 Month Assignment

A leading biotechnology company is seeking a Process Engineer to join the Manufacturing Operations department. The focus of this role is on continuous improvement, design, automation, cGMP compliance, and quality management within manufacturing processes. The Engineer will lead Lean Manufacturing initiatives to enhance efficiency and effectiveness.

Process Development Engineer Responsibilities:

• Process Engineering & Improvement:
  --Design, develop, and improve manufacturing processes for new and existing products (aiming for reduced cycle time).
  --Analyze process data and perform troubleshooting to resolve technical issues and decrease downtime.
  --Design and implement automation solutions to streamline processes.
  --Support process validation and qualification activities.
  --Utilize process simulation software and engineering tools for optimization.
  --Manage project timelines for equipment repairs, maintenance, and upgrades.
• Compliance & Quality:
  --Ensure strict adherence to current Good Manufacturing Practices (cGMP) and internal quality standards.
  --Maintain documentation (flow diagrams, work instructions, reports).
  --Conduct risk assessments and develop mitigation strategies.
  --Assist in audit readiness and Non-Conformance Report (NCR) investigations.
  --Identify and escalate potential safety hazards.
• Continuous Improvement:
  --Apply Lean principles to eliminate inefficiencies and waste.
  --Use problem-solving methodologies (e.g., Five Whys, Fishbone diagrams) for root cause analysis.
  --Use statistical tools (e.g., Minitab) to analyze data and generate actionable insights.
  --Establish and maintain Overall Equipment Effectiveness (OEE) improvement plans and track performance metrics.
  --Develop and maintain standardized procedures and documentation.
• Maintenance:
  --Develop and implement comprehensive preventive maintenance plans for manufacturing and test equipment.
  --Coordinate with maintenance teams for scheduled maintenance, service, and calibrations.

Process Development Engineer Qualifications:

• 2-5 years of relevant work experience.
• Bachelor's Degree (required), preferably in Engineering/Engineering Technology or a Life Science discipline.
• Basic knowledge of GMP and regulatory standards.
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.
• Knowledge of Lean principles and/or Six Sigma methodologies (preferred).

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